DE10028787A1 - Device for treating neurological, neuropsychological illnesses has components for specific indication of multiple, patient-individual neuro-feedback profile, monitored initial training - Google Patents

Abstract

The device has a flexible, integrated, multi-channel system containing components for specific indication of a multiple, patient-individual neuro-feedback profile and for monitored initial training. A modular, individually adjustable mobile device can be used in the home or outside a medical practice based on the protocol adapted to the central system to monitor, control and evaluate several simultaneous sessions independently of location. The neuro-feedback protocols can be reset via the Internet or using communications protocols.

Description

The invention relates to a device for the treatment of neurological and neuropsychological diseases.

It enables a methodical and technical realization of a patient-specific biofeedback system for spontaneous and evoked brain electrical activity based on a central and a portable Unit.

In the field of biofeedback or EEG biofeedback, there are different systems, devices and methods for use in clinical practice (US 3942516, US 4110918, US 5343871, US 5406957, US 5899867, US 5792047, US 5024235, WO 9405201). Basically, one can consider the following priorities when describing a biofeedback device:

• 1. type and number of signals recorded for the feedback;
• 2. Technical execution;
• 3. Processes used for signal analysis;
• 4. Type of feedback.

One of the most common device solutions offers the possibility of Feedback of several physiological signals, such as EMG, temperature, Breathing, skin conductivity and EEG. In the area of feedback the Apparatus that provide feedback from human brain activity exist different EEG components such as θ, α, β, SMR rhythm or Realize relationships of these brain activities. These devices offer the doctor the selection of predetermined neurofeedback protocols, whereby also prescribed electrode positions should be selected. A very often used in very different neuronal diseases The biofeedback method, for example, is based on the SMR rhythm. It is mostly highly unspecific, since the existing one Technology does not have enough flexibility and space for an individual design of the Offers treatment.  

Problems with the requirements of these tasks arise the limitations of the EEG device technology available on the market: the Measurement hardware usually does not allow the reliable acquisition of specific ones Signal components, the supplied software is mostly on Routine EEG examinations aligned and implemented only conventional Evaluation method. For controlling the feedback in EEG learning processes is a continuous online-capable monitoring of frequency and Changes in amplitude of basic rhythms necessary. Known EEG feedback controls are based on evaluations in longer time windows or signal sections. This is a feedback on the success of the Rhythm control only possible at intervals of a few seconds. It lacks especially high-resolution and topographical in time and frequency Methods that underline the dynamics of brain processes Taking into account the stochastic EEG character can be researched. This is the prerequisite for understanding the fine temporal Microstructure of physiological and pathological brain events is not available. Methods to demonstrate the specificity of the are also missing Neurofeedback therapy because of the various influencing factors and those used Validation of suitable characteristics not adequately extracted and checked can be.

Practice also shows that, for example, when training epileptic Patients based on the slow potential, the biofeedback sessions with a frequency of at least 2-3 sessions per week over one Period of several months should be carried out. This arises especially for working or remote patients than hardly feasible, so this type of treatment is often dispensed with.

The aim of the design of the system presented here is to Consideration of established and current neurological findings and using new signal processing algorithms, as well as under Inclusion of modern hardware and multimedia options a new one Biofeedback strategy and device for the treatment of neurological and to develop neuropsyhological diseases. The Methodological-technical solution includes a flexible, integrated Multi-channel system that contains components for the specific indication of a multiple, patient-specific neurofeedback profile and for a monitored Initial training includes. On the basis of this central system adapted protocol can be ported to a modular, individually adjustable mobile device for home use or outside of Doctor's office. Monitoring, control and evaluation of the several meetings taking place simultaneously, not necessarily in one place and re-setting the biofeedback protocols via the Internet or Communication protocols can thus also be implemented.

The object is achieved according to the invention with a device for patient-specific biofeedback treatment for spontaneous and evoked brain electrical activity on the basis of a central and a portable unit. This is characterized by:

• - Realization as a central system (ZS) and portable miniature system (PS) or practice home system;
• - A profiler integrated in the central unit, Decision support system, for the creation of a patient-specific profile on the basis of which the choice of those to be trained Activities and the objective validation of the biofeedback strategy with Using signal analysis methods and statistical tests against one Initial state and compared to a norm group;
• - Free interactive design of biofeedback protocols by the doctor in the form of mathematical functions, such as B.
  (Aα (O1) + Aα (Oz) + Aα (O2)) / Aθ (Oz)
  Sum of the amplitudes of the α activity under electrodes O1, Oz, O2 divided by the amplitude of the θ activity under electrode Oz
  (P [10-12] (Oz)) / (P [8-10) (Oz))
  Ratio of the instantaneous power (electrode Oz) of the activity in the frequency range 10 <= f <= 12 Hz compared to that in the frequency range 8 <= f <= 10 Hz
  F (P3)
  current frequency of activity under electrode P3
  ASMR (C3)
  SMR amplitude position C3
  SCP (C2)
  Slow cortical potential below Cz
  C (C4)
  local coherence position C4
• - Configuration of the software for the PS by the composition individual selected when setting the protocol on the ZS Software components and their porting from the ZS to the PS;
• - Monitoring, control and evaluation of meetings and the New setting of the biofeedback protocols via the Internet or via Communication protocols;
• - Monitoring and control of several, at the same time, not necessarily one place meetings (PS) about the ZS;
• - Free choice of feedback channel or cortical localization simultaneous monitoring of real signals and feedback parameters all recorded channels (ZS);
• - Possibilities for the simultaneous recording of not only EEG components such as θ-, α-, β- etc. but also slow components (SCP) and others polygraphic signals;
• - Possibility for acquisition and feedback of evoked potential through the use of numerous visual, acoustic and cognitive stimulations (ZS);
• - Variable duration and combinability of the feedback trials, the Interstimulus distances and the pauses (ZS);  
• - Choice of different signal processing methods or parameters for the same channel or for different channels and their simultaneous display to optimize the feedback protocol (ZS);
• - Use of adaptive recursive estimates as a basis for continuous online control of feedback (ZS, PS);
• - A multimedia feedback module that can be customized by choice or Import of music, film files or pictures by the doctor if necessary can be configured by the patient. The sensitivity of the feedback is also individually adjustable (ZS, PS). The goal here is an optimal one To achieve learning process with maximum psychological impact;
• - Control films as feedback, d. H. playing the film will only as long as the corresponding activity takes place in the desired one Direction is controlled. Otherwise the playback is stopped;
• - Realization of the ZS as two monitor systems (patient, doctor monitor) either as a 2PC system (communication e.g. via RS232 or TCP / IP) or as a 1PC system when using internal communication (DDE, TCP / IP);
• - Compatibility with common polygraphic and EEG systems and thereby realization on the basis of commercially available devices and no special hardware solution (ZS);
• - Optional use of monitor, video panel, LCD glasses or on Head-mounted display for feedback (ZS, PS).
• - Realization of the portable miniature system on the basis of portable Computers, "body-worn" computers, palm tops or game consoles (PS).

Because of the high functionality, flexibility and the possibilities for one individual optimization will not only increase the efficiency of the Neurofeedback training increased, but there will be new ones Treatment perspectives through the design of new biofeedback protocols opened. Last but not least, the portable solution gives the patient one inexpensive alternative offered that is date independent and therefore free planning allowed. Furthermore, the combination of a ZS with several horsepower, e.g. B. in hospitals or biofeedback studios for Control of patients biofeedback monitoring rooms can be set up and this saves personnel.

The starting point is the quantification of the EEG ( Fig. 1), which was derived using long-term monitoring. In this way, parameters describing the patient's condition can be obtained from the EEG, which was recorded at rest or, depending on the application, during different provocation methods. A patient-specific profile is created using a predefined vector of parameters. In addition to the quantities resulting from the quantification, this profile also includes patient-specific data such as B. Information about the current emotional state and the environment is recorded. The patient-specific profile is then used to determine the strategy for neurotherapy (NT) or biofeedback (BF). During the first BF sessions to be designated as initial, monitoring of the real signals and the feedback parameters is also carried out across all recorded channels. A choice of different signal processing methods for the same or different channels is also possible. After determining the optimal method for the patient - i.e. choosing the activity, the cortical location, the calculation method, the start resolution of the feedback and the modalities of the stimulation paradigms, in the event of evocation, either on the central system or on the home system (after porting of the corresponding modules) a certain number of training procedures are carried out. Long-term monitoring with subsequent quantification can then be carried out again. The profile is continuously expanded with the newly acquired parameters. Comparisons between the state vectors can be carried out on the basis of selected statistical methods and according to predefined criteria. The result is used to assess the success of the NF therapy used. The results of the evaluation serve to adapt the treatment method. This would mean that if an activity is not successfully controlled, it can be replaced in future therapy sessions by controlling another activity or by combining the control of different EEG bands.

As can be seen in Fig. 2, the central biofeedback system consists of the following components, regardless of the practical implementation:

• - control of measurements and stimulation;
• - signal acquisition;
• - signal processing;
• - signal presentation;
• - feedback;
• - stimulation (optional).

The use of multi-channel leads is essential for the initial phase in neurofeedback examinations. This procedure clearly allows one improved consideration of the correlation of functional and morphological findings. It is expected that by considering the topographical peculiarities of the pathological EEG signals and through an efficient online monitoring a patient-specific and more effective neurofeedback therapy can be designed. Furthermore, should other biological signals are derived simultaneously. That way you can valuable conclusions about time-correlating side effects or other physiological or pathological processes and in the  Future in biofeedback.

To the possibility of complete information about the expiring to get physiological processes, polygraphic data, including z. B. the EEG, the VEOG, the HEOG, the EKG and the Breath curve. For the derivation of the EEG International 10-20 system locations used. The derivatives are performed referentially against the connected mastoids. Other assemblies such as transverse, longitudinal and temporal are possible. The Transition impedances are brought to values <3 kΩ. The setting of the Filter is in the range 0-70 Hz, whereby DC (0 Hz) is only slower with the derivation Potentials (SCP) is necessary. The sampling rate is between 100 and 500 Hz. The other signals are derived bipolar. The EEG and the EOG are performed using sintered Ag / AgCl electrodes. The breathing curve is recorded using a breathing belt.

The one that follows after the initial investigation and feedback session Biofeedback training takes place using a greatly reduced number of electrodes, which depends on the choice of activity.

The neurofeedback system should be flexible and the doctor should Give opportunity for experimentation. For this reason, the Requirements for a control of evoked as well as of spontaneous activity can be created. In the first case, in addition to those in the Neurological routine also established numerous provocation methods Stimulation procedures needed.

A large number of the stimulations are based on the S1-S2 paradigm [Rockstroh et al., 1982] ( Fig. 3), the interstimulus interval (ISI) being in the seconds range (usually 6 s). The S1-S2 paradigm means that a certain stimulus S1 announces a second stimulus S2.

Depending on the expected S2 and the way S1 is presented (acoustically or visually, continuously or not over the entire ISI), an expectation is built up during the ISI that is reflected in a specific DC shift. In order to influence this shift, different S1-S2 pairs are used in the stimulation paradigm. A certain S1 announces an aversive S2, while another, easy to differentiate S1 announces a neutral S2. The paradigm explained here is implemented in different ways:

• - simple stimulations
  A simple implementation of the S1-S2 paradigm is that different tones are selected as S1 and S2. A high tone announces an aversive S2, while a lower tone announces a neutral S2. S1 is presented continuously over 6 s and S2 over 4 s. There is a pause of 4 s after each sequence (S1, S2).
  A second variant used for all measurements consists in the announcement of an image by S1. Here, too, a visual aversive S2 is announced by a high tone as S1, and a neutral S2 by the lower tone. Then there is a pause of 4 s.
• - more complex stimulations
  More complex S1-S2 paradigms contain the subject's reaction to a specific task ( Fig. 4). With this stimulation, an S1 announces more difficult and a second S1 relatively simple computing tasks. The tasks are presented with results and the test person must decide whether this is correct or incorrect and press a corresponding key. After a subsequent waiting time of 4 s there is visual feedback as to whether his decision was right or wrong.
  For measurements with a frequency-changing checkerboard, the paradigm is changed in such a way that the S1, which announces the neutral S2, announces slow frequencies (5 and 10 Hz) here. The other S1 comes before faster frequencies (15 and 20 Hz). The frequency changes take place at 5 Hz starting at 10 and 15 to 20 Hz and back again.
• - Special stimulations
  Special stimulations are available for the examination of excitation states in the cortex, as well as for control measurements to determine influences on the generated slow shifts. On the one hand, two individual visual stimuli are inserted in the pauses of the checkerboard ramp explained above in order to generate a VEP, the amplitude of which could provide information about the excitation state of the cortex region.
  In addition, stimulations for control measurements are implemented in which the stimuli are interchanged (S1 visual, S2 acoustic), the acoustic or visual S1 are only presented very briefly or only the S1 or S2 are presented separately. The influences of the design of the stimulation on the measured DC shift can thus be determined.
  When creating the stimulations, the sequences are repeated several times. The sequence of the sequences was determined at random. In addition, both ISI and pause times can be flexibly changed for all paradigms.

For the creation of stimulations in the cognitive area Components of the International Affective Picture System (IAPS) [Lang et al., 1997], a system with statistically verified and according to different Criteria classified images - used. This allowed the choice of Stimulators are based on objective criteria. With the help of the IAPS were special age-appropriate stimulations, e.g. B. created for children.  

The demand for flexibility implies the consideration of a larger one Number of spontaneous and evoked portions of brain activity. It will be first Place signals selected, their experimental use within the framework of a Neurofeedback procedure associated with a positive therapeutic effect has been. Examples of such EEG rhythms are θ, α, β, SMR rhythm or combinations of these. The CNV and possibly some of the cognitive components. There will be additional Relationships between different cortical locations, like that bilateral asymmetries. The overlay of the relevant EEG signals with a variety of biological and artifacts non-biological origin makes efficient preprocessing indispensable. The choice of methods and algorithms must be based on this Make a compromise in the sense of a due to the real-time capability optimal signal quality.

The routines of signal processing form the core of a neurofeedback system. The results of the potential evaluation are used in four different ways:

• - for artifact reduction;
• - for presentation of results and control by the doctor or the medical-technical staff. A combination of the directly measured and calculated size created and displayed become;
• - to control the feedback;
• - for later off-line evaluation of the NF session and for statistical purposes Comparison with previous sessions or with existing ones Average data.

In the first three cases, only on-line processes are possible, or processes in which the evaluations are carried out on the basis of epochs (quasi on-line). Methods of the following groups are implemented according to the calculation type:

• - Methods based on windows, e.g. B. the FFT, baseline calculation, Averaging, correlations, VEOG, HEOG correction;
• - Recursive methods such as B. the adaptive recursive estimates (ARE) [Grießbach et al., 1993a], [Grießbach et al., 1993b], [Grießbach et al., 1994a], [Grießbach et al., 1994b].

By control via the control parameter calculated from the measurement data the current status of the feedback stands for a specific, measured physiological condition of the patient. The real feedback is that this condition through a multimedia representation for the patient becomes perceptible (acoustically, visually or audiovisually) and through them Representation of a change in this state, within the scope of Training procedure, first recorded and then trained. The design  the feedback should be simple and not too complex and age-related his. In the system presented here, the feedback is in the form of high qualitative animations, films and pieces of music via RS323, DDE or TCP / IP can be controlled, realized. It is both motion-oriented as well as performance-oriented types implemented. A Adaptation of the feedback resolution to the patient's options (within the individual parameter range of the signal to be controlled) possible. The files required for the control mechanism (images, Music, films) can be selected in certain formats by the doctor and possibly introduced by the patient.

The basis of the central system is a polygraphic EEG device (DC-AC amplifier). This offers the possibility of measuring arrangements to be flexible. A possible configuration would be, for example: 28 unipolar channels EEG and 4 bipolar channels for VEOG, HEOG, EKG and Breathing.

In order to establish the required feedback, the data stream must first be transmitted from the amplifier to the measuring computer. A parameter that is used to control the feedback is then calculated from the raw data ( Fig. 5).

The design of the control of the feedback in the three ways described (via RS323, DDE or TCP / IP) allows the implementation of the central system using two PCs and two screens or else by a PC and one or two screens. The portable unit is realized on the basis of portable computers, "body worn" computers, palm tops or game consoles. Both the central and the portable system can either use common monitors, e.g. B. TFT displays, as well as special LCD glasses with integrated headphones, such as a personal LCD monitor or a "head mounted" display. The options mentioned allow additional miniaturization and mobile use of the portable solution ( Fig. 6).

credentials

[Grießbach; 1990]
Grießbach, G.:, Computer-oriented measurement stochastics in technical diagnosis and signal mapping, habilitation thesis Friedrich-Schiller-Universitat Jena, Math. Faculty, 1990.
[Grießbach et al., 1993a]
Grießbach, G., Schack, B., Adaptive Quantile Estimation and its, Application in Analysis of Biological Signals, Biometrical Journal, Vol. 35, 1993, no. 2, 165-179.
[Grießbach et al., 1993b]
Grießbach, G., Witte, H., Schack, B .: Possibilities of using dynamic spectral parameters in biosignal analysis. Biomedical Engineering, 38, 1993, pp. 81-82.
[Grießbach et al., 1994a]
Grießbach, G., Schack, B., Putsche, P., Bareshova, E., Bolten, J .: The Dynamic Description of a Stochastic Signal by its Adaptive Momentary Power and Momentary Frequency Estimation and its Application to Biological Signals, Medical & Biological Engineering and Computing

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[Grießbach et al., 1994b]
Grießbach, G., Schack, B., Anders, Ch., Schumann, NP, Scholle, H. Ch., New possibilities for temporal parametric frequency analysis in multi-channel surface EMG, in: Motodiagnostik Mototherapie II, Universitätsverlag Jena, 1994, Pp. 179-184.
[Grießbach et al., 1994c]
Grießbach, G., Schack, B.,: Detection and description of dynamic changes in image sequences using adaptive methods, congress volume "Digital Image Processing in Medicine" of the GMDS, Freiburg

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[Rockstroh et al., 1982]
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Claims (20)

1. Device for the treatment of neurological and neuropsychological diseases, characterized in that the methodical-technical solution includes a flexible integrated multi-channel system that includes components for the specific indication of a multiple, patient-specific neurofeedback profile and for a monitored initial training, based on the This central system-adapted protocol can be ported into a modular, individually adjustable mobile device for use at home or outside the doctor's office in order to monitor, control and evaluate (on- and off-line) that of several, simultaneously, not necessarily to implement meetings and new settings of NF protocols in one place via the Internet or communication protocols. 2. Device according to claim 1, characterized in that the Biofeedback training based on a methodical-technical solution as central system (ZS) and portable miniature system (PS) or Practice home system is realized. 3. Apparatus according to claim 1, characterized in that in the a profiler decision support system for the central unit Creation of a patient-specific profile for the choice of those to be trained Activities and the objective validation of the biofeedback strategy at the Basis of signal analysis methods and statistical comparisons against one Initial state and integrated with a standard group. 4. Apparatus according to claim 1 and 3, characterized in that a free interactive design of biofeedback protocols by the doctor in the form of Mathematical functions are defined. 5. Apparatus according to claim 1 to 4, characterized in that individual Software components configured by the choice of protocol in the portable systems are transmitted. 6. The device according to claim 1 to 5, characterized in that a Monitoring, control and evaluation of meetings and new hiring of Biofeedback protocols implemented via the Internet or communication protocols becomes. 7. The device according to claim 1 and 2, characterized in that a Monitoring and control of several, at the same time, not necessarily  a place, meetings (PS) about the ZS in the sense of a NF monitoring is realized. 8. The device according to claim 1 to 4, characterized in that the Feedback channel or cortical localization with simultaneous monitoring the real signals and the feedback parameters of all recorded channels freely selected can be. 9. The device according to claim 1 to 4, characterized in that a simultaneous acquisition of not only EEG components such as θ, α, β etc. but also of SCP and other polygraphic signals. 10. The device according to claim 1 to 4, characterized in that the Acquisition and feedback of evoked potentials through use numerous visual, acoustic and cognitive stimulations are integrated. 11. The device according to claim 1 to 4, characterized in that the Duration and combinability of the feedback trials, the interstimulus distances and the breaks are chosen variably and individually. 12. The apparatus according to claim 1 to 4, characterized in that different signal processing methods for the same or different channels selected and simultaneously presented for comparison become. 13. The apparatus of claim 1 and 12, characterized in that adaptive recursive estimates as the basis for continuous online control serve the feedback. 14. The apparatus according to claim 1 and 2, characterized in that a individualized content design of the multimedia feedback and there is a variable individual feedback sensitivity. 15. The apparatus according to claim 1 and 14, characterized in that a Porting of any piece of music, films and images by the doctor or patients is possible. 16. The apparatus according to claim 15, characterized in that the Control films as feedback, d. H. playing the film only as long how to control the corresponding activity as desired, is integrated. 17. The apparatus according to claim 1 and 2, characterized in that the central system as two monitors system (patient, doctor monitor) either as 2 PC system (communication - RS232, TCP / IP) or as 1PC system the use of internal connections (DDE, TCP / IP) is established.   18. The apparatus according to claim 1 and 2, characterized in that a commercially available polygraphy system and not a special one Hardware solution for the central system is used. 19. The apparatus according to claim 1 and 2, characterized in that Monitor or video panel, LCD glasses or display attached to the head for the feedback is chosen. 20. The apparatus according to claim 1 and 2, characterized in that the portable system based on portable computers, "body-worn" computers, palmtops or game consoles.